A Phase 2 Randomised Controlled Trial of a NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier in Adults With a Predisposition to a Skin Barrier Defect

Detailed Summary

Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease and it is characterised by exacerbations or relapses over years. The patients have a genetically impaired skin barrier that can be evaluated by measuring the transepidermal water loss (TEWL), which is increased in both dry skin and clinically normal skin in AD patients. Moisturisers are first line treatment for AD patients and moisturisers are the most prescribed products in dermatology. The use of moisturisers have been found to reduce the need for steroids. The newly developed moisturizing cream 1107.57 is intended for people with dry skin symptoms, such as dryness, itching, and flaking. As most people with dry skin of different origin have an impaired skin barrier function, it is important to investigate the possible influence on the skin barrier after long-term (several weeks') treatment. It is of utmost importance to evaluate different moisturisers head-to-head in order to facilitate an evidence-based choice of moisturiser. The primary objective of the trial is to determine whether applying the test cream 1107.57 for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) two reference creams in adults with a predisposition to a skin barrier defect. Secondary objectives are to determine whether there is a difference between 1107.57 and (1) no treatment and (2) the two reference creams in skin moisturization, tolerability, cream consumption and safety. Participants will treat their lower volar forearms for 28 days with three different creams (test cream and two reference creams) and leave one area untreated as a control. Each forearm will have two different treatment areas and treatment allocation will be randomized. One Finger Tip Unit (FTU) of each cream will be applied twice daily on the designated study area for 28 days. On day 1 and 29 the transepidermal water loss (TEWL) and skin capacitance is measured on their forearms to evaluate the effect on skin barrier function and skin hydration. Furthermore, on day 31, after challenge with 1 % sodium lauryl sulphate (SLS) on day 29, the susceptibility to irritation caused by SLS will be evaluated visually and by measuring TEWL on their forearms. Study participants will attend visits at the start of randomised therapy and on day 5, 15, 29 and 31. During the study period the participants will also grade and evaluate the tolerability of the different creams.

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